Dipotassium 3,4,5,6-tetrabromophthalate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Although the work was performed on the tetrachloro derivative instead of tetrabromo, the effects observed would not have been due to the presence of chlorine ions and can be attributed to the phthalic acid. The anhydride use in the test would quickly form as the acid on ingestion.
The substance is considered a valid read-across surrogate as the potassium salt will dissociate and behave in the same was as the acid form when exposed to biological media.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 477 (Genetic Toxicology: Sex-linked Recessive Lethal Test in Drosophila melanogaster)

Principles of method if other than guideline:

somatic mutation and recombination test in Drosophila

GLP compliance:

not specified

Type of assay:

somatic mutation and recombination test in Drosophila

Test material

Test material information

Constituent 1

Reference substance name:

Tetrachlorophthalic anhydride

EC Number:

204-171-4

EC Name:

Tetrachlorophthalic anhydride

Cas Number:

117-08-8

Molecular formula:

C8Cl4O3

IUPAC Name:

Tetrachlorothphalic anhydride

Test animals

Species:

Drosophila melanogaster

Sex:

male

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

Saline and/or peanut oil

Details on exposure:

Single injection

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 ppm

Doses / concentrations 2

Dose / conc.:

500 ppm

Control animals:

yes, concurrent vehicle

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

not examined

Applicant's summary and conclusion

Conclusions:

Although methods and results were not reported in good detail, the research has been cited and accepted by the US National Toxicity Program.

The work was performed on the tetrachloro derivative instead of tetrabromo, the effects observed would not have been due to the presence of chlorine ions and can be attributed to the phthalic acid. The anhydride use in the test would quickly form as the acid on ingestion.
The substance is considered a valid read-across surrogate as the potassium salt will dissociate and behave in the same was as the acid form when exposed to biological media.